Brand Name | NEOMED FEEDING TUBE WITH ENFIT CONNECTOR |
Type of Device | DH NASOGASTRIC (NG) FEEDING TUBES (NEOMED AND NEOCONNECT) |
Manufacturer (Section D) |
AVANOS MEDICAL INC. |
5405 windward parkway |
alpharetta GA 30004 |
|
Manufacturer (Section G) |
NINGBO TIANYI MEDICAL APPLIANCE CO., LTD. |
no.788, mozhi north rd |
tourism resort, dongqian lake |
ningbo zhejiang, cn 31512 1 |
CH
315121
|
|
Manufacturer Contact |
ujjal
chakravartty
|
5405 windward parkway |
alpharetta, GA 30004
|
4704485487
|
|
MDR Report Key | 18705761 |
MDR Text Key | 335377736 |
Report Number | 3011270181-2024-00017 |
Device Sequence Number | 1 |
Product Code |
FPD
|
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | UNKNOWN |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Other,Health Professional,User Facility |
Reporter Occupation |
Other Health Care Professional
|
Type of Report
| Initial |
Report Date |
02/14/2024 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 02/14/2024 |
Is this an Adverse Event Report? |
Yes
|
Is this a Product Problem Report? |
No
|
Device Operator |
Health Professional
|
Device Model Number | UNKNOWN |
Device Catalogue Number | N/A |
Device Lot Number | UNKNOWN |
Was Device Available for Evaluation? |
Yes
|
Is the Reporter a Health Professional? |
Yes
|
Was the Report Sent to FDA? |
No
|
Date Manufacturer Received | 01/18/2024 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Is the Device Single Use? |
Yes
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Unknown
|
Patient Sequence Number | 1 |
Treatment | DONOR HUMAN MILK [DHM]; ENDOTRACHEAL TUBE [ETT] |
Patient Outcome(s) |
Other;
Required Intervention;
|
Patient Sex | Male |
Patient Weight | 1 KG |
Patient Ethnicity | Non Hispanic |
Patient Race | Black Or African American |